Health Law Keyed to Furrow
Bearder v. Minnesota
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Minnesota state law allows the screening of newborns for certain metabolic disorders. This results in the testing of the blood of more than 73,000 children and finding about 100 affected by such disorders each year. The screening of newborns is done under the authority of the newborn screening statutes, which (1) require the Commissioner of Health to prescribe the manner of testing, recording, and reporting of newborn screening results; (2) require those who perform screenings to inform parents that the blood samples and test results may be kept by the Department of Health; and (3) allow parents to either decline having their infants tested or require the blood samples and test results be destroyed after the screening. The screening process usually uses about 70 percent of the sample. If a portion of the blood sample remains after the screening tests are completed, the sample is kept indefinitely unless there is a specific request for it to be destroyed. The Defendant's Department of Health contracts with Mayo Medical Laboratories to perform screening tests on newborn children's blood samples. This contract allows Mayo to use excess blood samples for studies not related to the newborn screening program if, and in addition to other requirements, the samples have been de-identified or Mayo has obtained the written consent from the children's parent or legal guardian. The State Genetic Privacy Act states that "genetic information" about an individual: (1) may be collected by a government entity, or any other person only with the written informed consent of the individual; (2) may be used only for purposes the individual gave written informed consent for; (3) may be stored for only a short time which the individual gave written informed consent; and may be disseminated only: (i) with the individual's written informed consent; or (ii) if necessary in order to achieve purposes described by clause (2). A consent to disseminate genetic information under item (i) must be signed and dated. Unless otherwise provided by law, such a consent is valid for one year or for a lesser period as specified in the consent. Plaintiff and eight other families sued Defendant claiming that the Genetic Privacy Act required the Department of Health to obtain informed consent before it is permitted to collect, use, store, or disseminate the remaining blood samples after a newborn health screening has been completed. Defendant argued that the Genetic Privacy Act did not limit the Department's handling of the samples because (1) blood samples received by the Department of Health are not "genetic information" under the Act, and (2) the newborn screening statutes "expressly provide" that the Department of Health may use, store, and disseminate the genetic information without first having obtained written informed consent. The district court granted Defendant's motion to dismiss. The families (Plaintiff) appealed.
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